Ex-FDA Chief Claims AbbVie Promoted AndroGel for ‘Off-Label’ Uses

AndroGel

Kessler was called by attorneys for Jeffrey Konrad as the first witness in the first bellwether trial challenging AbbVie’s marketing of Androgel, which Konrad says caused him to have a heart attack in 2009.

Androgel’s labeling at the time did not mention age-related testosterone loss among the medicine’s approved uses.

“What the companies in essence did was to take those indications of low testosterone in men for specific reasons [and] the company in essence broke that link,” Kessler said. “It was no longer [being marketed] for specific diseases; it was for low testosterone for a broad range of issues.”

Konrad is one of about 4,200 plaintiffs in lawsuits accusing AbbVie of promoting Androgel for “Low T,” a made-up term for the natural aging process which includes symptoms such as fatigue, loss of sex drive and mood swings.

The complaints were consolidated into a multidistrict litigation (MDL No. 2545) in the U.S. District Court for the Northern District of Illinois for pretrial handling before Judge Matthew F. Kennelly.

AbbVie and other testosterone manufacturers pushed for unapproved or “off-label” sales without adequately testing the drugs, and ignored studies which suggested that TRT could increase the risk for blood clots, stroke, heart attack and other serious side effects, according to the complaints.

Source: Law360